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This study aims to investigate the safety and efficacy of semaglutide in patients with Idiopathic intracranial hypertension.
Idiopathic intracranial hypertension (IIH) is a condition characterized by elevated pressure within the skull for reasons that are not yet understood. This condition does not involve abnormalities in the cerebrospinal fluid or any structural brain damage. Individuals with this condition commonly experience persistent headaches, and some may face the potential of irreversible vision loss, significantly impacting their psychological well-being and overall quality of life. At present, the efficacy of medications like acetazolamide and topiramate in managing IIH is constrained by practical clinical constraints. Recent studies have indicated that glucagon-like peptide-1 receptor agonists show promise as a potential treatment option for IIH. Semaglutide, as a long-acting glucagon-like peptide-1 formulation, has a half-life of up to 160 hours and only needs to be injected once a week. It is easy to administer and has good safety and tolerability. Hence, the objective of this study is to investigate the effectiveness and safety of semaglutide in managing idiopathic intracranial hypertension, laying the groundwork for subsequent extensive, multicenter research endeavors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | Expanding on the usual treatment regimen, Semaglutide is administered through a subcutaneous injection once weekly over a period of 3 months. Initially, the dose is 0.25 mg for the first month, then increased to 0.5 mg for patients who could tolerate it in the second month, and finally raised to 1.0 mg for patients who still tolerated it in the third month. |
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| Usual treatment | Active Comparator | Usual treatment refers to the 2018 consensus guidelines on the management of IIH. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | Giving Semaglutide via subcutaneous injections on a weekly basis for a duration of 3 months. The dosage is 0.25 mg for the initial month, then upped to 0.5 mg for patients who could handle it in the second month, and eventually escalated to 1.0 mg for patients who continued to tolerate it in the third month. |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial pressure | The intracranial pressure is represented by the cerebrospinal fluid pressure measured by lumbar puncture in a lateral position. | 12 weeks |
| Adverse reactions | Adverse reactions include gastrointestinal reactions (such as nausea, vomiting, diarrhea), hypoglycemia, allergic reactions (such as rapid allergic reactions, vascular edema). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Headache severity | It is measured by the questionnaire "Headache Impact Test-6" (HIT-6); score range is 36-78. The higher the score, the more severe the headache. | Baseline + 12 weeks |
| Degree of papilledema |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xunming Ji, MD PhD | Contact | +86-83198952 | jixunming@vip.163.com |
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
| D031204 | Caloric Restriction |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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The researchers are tasked with adhering to the protocol requirements when selecting participants, and consistently enrolling eligible patients who are then randomly assigned to either the experimental or control group in a 1:1 ratio. The randomization process is overseen by expert statisticians and executed by specialized clinical researchers in an independent manner.
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| Low calorie diet | Dietary Supplement | Low calorie diet (max 1200 kcal/day) |
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It is represented by the Frisén Grade (0-5, 0 is the minimal, 5 is the worst) measured by fundoscope.
| Baseline + 12 weeks |
| Perimetric mean deviation | It is measured by Humphrey automated perimetry. | Baseline + 12 weeks |
| Optic nerve sheath diameter | It is measured by optic nerve sheath ultrasound. | Baseline + 12 weeks |
| Body mass index | Change in body mass index. | Baseline + 12 weeks |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |